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Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe Rx

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Product Description
Sileo (Dexmedetomidine Oromucosal Gel) is the first and only FDA-approved prescription medication for the treatment of canine noise aversion. It is a synthetic alpha-2 adrenoceptor agonist. Each ml of SILEO contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride). Because Sileo is formulated to provide a low dose of dexmedetomidine, the dog remains calm, yet fully functional, and is able to interact normally.
What is Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe?
Sileo (Dexmedetomidine Oromucosal Gel) is the first and only FDA-approved prescription treatment for canine noise aversion.
Who is Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe for?
Dogs (16 weeks of age or older)
Why use Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe?
-Calming without sedating, allowing for normal dog-owner interactions -Easy to administer at home, when needed -Works on its own without any other treatments or training -Quick onset of action -Proven to be safe and effective in a randomized, placebo-controlled clinical trial -An easy treatment for a challenging condition
How does Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe work?
Sileo works by blocking norepinephrine, a brain chemical similar to adrenaline that pumps up anxiety.
Manufacturer:
Zoetis
Active Ingredients(s):
Dexmedetomidine Hydrochloride
How is Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe sold?
Dexmedetomidine Oromucosal 0.09 mg/ml, 3 ml syringe
What are the side effects of Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe?
No serious adverse reactions are attributed to the administration of dexmedetomidine oromucosal gel in dogs.
What special precautions are there?
Do not use SILEO in dogs with severe cardiovascular disease, respiratory, liver or kidney diseases, or in conditions of shock, severe debilitation or stress due to extreme heat, cold or fatigue or in dogs hypersensitive to dexmedetomidine or to any of the excipients. SILEO should not be administered in the presence of preexisting hypotension, hypoxia or bradycardia. Do not use in dogs sedated from previous dosing. SILEO has not been evaluated in dogs younger than 16 weeks of age or in dogs with dental or gingival disease that could have an effect on the absorption of SILEO. SILEO has not been evaluated for use in breeding, pregnant or lactating dogs. Transient pale mucous membranes at the site of application may occur with SILEO use. Other uncommon adverse reactions included emesis, drowsiness or sedation. Handle gel-dosing syringes with caution to avoid direct exposure to skin, eyes or mouth. WARNINGS: Human Safety: Not for human use. Keep out of reach of children. *Avoid administering the product if pregnant, as exposure may induce uterine contractions and/or decrease fetal blood pressure. Appropriate precautions should be taken while handling and using filled syringes. Impermeable disposable gloves should be worn when handling the syringe, administering SILEO, or when coming in contact with the dog’s mouth after application.
What to do if overdose?
Contact your nearest emergency animal hospital
How can I store Sileo Gel for Dogs (Dexmedetomidine Oromucosal) 0.09 mg/ml, 3 ml syringe?
Store unopened and opened syringes in the original package at controlled room temperature 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). Use syringe contents within 2 weeks after opening the syringe.
Overview
DOSAGE AND ADMINISTRATION:
SILEO is administered onto the oral mucosa between the dog’s cheek and gum at the dose of 125 mcg/m2. The gel is absorbed through the oral mucosa and therefore it
should NOT be swallowed. If the gel is swallowed, the product may not be effective. If the gel is swallowed, do not repeat the dose for at least two hours.
The following table provides the acceptable dosage for each weight range. Each dot (●) represents 0.25 mL of SILEO.
Each ml contains the equivalent to 0.1mg dexmedetomidine hydrochloride.
 
Dosage by body weight :
Bodyweight (lb)  /  Number of dots
4.4-12.1                       1 ●
12.2-26.5                     2 ●●
26.6-44.0                     3 ●●●
44.1-63.9                     4 ●●●●
64.0-86.0                     5 ●●●●●
86.1-110.2                   6 ●●●●●●
110.3-137.8                 7 ●●●●●●●
137.9-166.4                 8 ●●●●●●●●
166.5-196.2                 9 ●●●●●●●●●
196.3-220.5              10 ●●●●●●●●●●
 
* If the dose is more than 6 dots, divide the dose between both sides of the mouth
 
The first dose can be administered:
Approximately 30 to 60 minutes before the fear and/or anxiety eliciting noise stimulus
Or immediately after the dog shows first signs of anxiety or fear related to noise
Or when the owner detects a typical noise stimulus (e.g., fireworks) eliciting anxiety or fear in the dog
 
If noise lasts greater than 2–3 hours and the dog’s signs of fear and/or anxiety reappear, another dose may be given:
At minimum intervals of 2 hours between doses
Up to five doses can be given during one noise event
Main Ingredients
Dexmedetomidine Oromucosal 0.09 mg/ml, 3 ml syringe